Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients.
BACKGROUND
Totally Implantable Access Ports (TIAP) are being extensively used world-wide and can be expected to gain further importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two different techniques for the implantation can be selected: A direct puncture of a central vein and the utilization of a Seldinger device or the surgical Venae Sectio. It is still unclear which technique has the optimal benefit/risk ratio for the patient.


METHODS
A single-center, expertise based randomized, controlled superiority trial to compare two different TIAP implantation techniques. 100 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective implantation of a TIAP under local anesthesia who signed the informed consent will be included. The primary endpoint is the primary success rate of the randomized technique. Control Intervention: Venae Sectio will be employed to insert a TIAP by a surgeon;


METHODS
Punction of V. Subclavia will be used to place a TIAP by a radiologist. Duration of study: Approximately 10 months, follow up time: 90 days.
The PORTAS 2 - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Center of Clinical Trials at the Department of Surgery, University Hospital Heidelberg is responsible for design and conduct of the trial including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI), University of Heidelberg.


BACKGROUND
The trial is registered at ClinicalTrials.gov (NCT00600444).
Knebel
Philip
P
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany. philip.knebel@med.uni-heidelberg.de
Fischer
Lars
L
Cremonese
Eva
E
Lopez-Benitez
Ruben
R
Stampfl
Ulrike
U
Radeleff
Boris
B
Kauczor
Hans-Ulrich
HU
Büchler
Markus W
MW
Seiler
Christoph M
CM